EchocardiographyNCT06695065
Value of Speckle Tracking Echocardiography Inflammatory Bowel Disease Patients
An observational study of Echocardiography and Inflammatory Bowel Diseases, run by Assiut University.
Trial summary
Value of speckle tracking echocardiography in early assessment of cardiac function in inflammatory bowel disease . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Echocardiography, Inflammatory Bowel Diseases, Cardiac Function
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: History: Demographic data; age, sex. History of the disease: onset, duration, medication. Family history of disease. History of comorbidities: hypertension, diabetes, ischemic heart diseases. Laboratory investigations: Fasting blood glucose, 2 hr postprandial and glycated haemoglobin A1c (HbA1c). Lipid profile: LDL, HDL, triglyceride, cholesterol. Inflammatory markers: CRP, ESR Complete blood picture Evaluation of Disease Severity Partial Mayo score consists three of the four components of the standard Mayo score, excluding endoscopic findings (stool frequency, rectal bleeding and physician's global assessment). Each component is assigned a score of 0-3, and total score ranges from 0 to 9 for each patient. -Echocardiographic Examination
Who may be able to join
- Age (18-60) yrs.
- Both sexes.
- Patients with IBD either in active form or in remission.
Who cannot join
- Patients with ischemic heart disease. -Patients with other comorbidities affecting heart as uncontrolled hypertension or diabetes. -
- Pregnant females.
- Malignancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Value of Speckle Tracking Echocardiography in Early Assessment of Cardiac Function in Inflammatory Bowel Disease Patients
Value of speckle tracking echocardiography in early assessment of cardiac function in inflammatory bowel disease .
Read the detailed description
Ulcerative colitis (UC) is a common form of inflammatory bowel disease (IBD) that consists of chronic inflammatory disorders of the colon and the small intestine with unknown etiology. Chronic inflammation is the basis of complicated pathogenesis, and the course of the disease is often complicated by an immune response. Malnutrition, malabsorption and the involvement of organs other than those of the gastrointestinal tract are frequent consequences of the disease . Although extra-intestinal manifestations of IBD are common (ranging from 6% to 47%), cardiac involvement is rare.
Inflammatory bowel disease (IBD) is a known risk factor for cardiovascular disease (CVD). IBD patients have a two- to threefold increased risk of venous thromboembolism, particularly during acute flares when disrupted homeostasis of anti- and procoagulants leads to a hypofibrinolytic state. Cardiovascular manifestations in Crohn's disease (CD) and ulcerative colitis (UC) include conditions such as Takayasu's arteritis, pericarditis, and myocarditis. Chronic inflammation and altered lipid metabolism, along with long-term use of anti-inflammatory drugs (e.g., corticosteroids, TNF-α inhibitors), are thought to drive CV pathology in IBD. Additionally, chronic inflammation is linked to pathological collagen deposition in affected organs.
Although conventional echocardiography is a widely accessible and easy tool to detect cardiac abnormalities, novel echocardiographic techniques and indices offer easy, reproducible and quantitative information for evaluating left ventricle function and subclinical changes . Speckle tracking echocardiography (STE) is an advanced echocardiographic methodology for the quantification of myocardial function. STE has been successfully used to identify early subclinical cardiac involvement in a variety of asymptomatic populations with chronic diseases and unremarkable conventional echocardiography. Unlike earlier echocardiography techniques, two-dimensional speckle tracking echocardiography (2DSTE) is less angle-dependent. In addition, STE is not affected by the rotation of the heart and allows heart functions to be examined segment by segment from various echocardiographic views . Despite, studies have examined subclinical cardiac impairment in patients with IBD, to the best of our knowledge, none have explored the impact of ulcerative colitis activity on cardiac function through using STE.
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group adult with ulcerative colitis | 50 Adult patients with ulcerative colitis | |
| control group | 50 age and sex matched control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subclincal cardiovascular events in IBD patients.
Assessment the predictive ability of Speckle TRACKING Echocardiograpy in development of subclinical cardiovascular events in IBD patients.
Measured: through study completion, an average of 2 year
Relation between isease activity and cardiac function
Evaluation of the relationship between disease activity and cardiac function as measured by Speckle tracking Echocardiograpy.
Measured: through study completion, an average of 2 year
Secondary outcomes (1)
correlation of Speckle TRACKING Echocardiograpy findings with traditional echocardiographic parameters
Detection of correlation of Speckle TRACKING Echocardiograpy findings with traditional echocardiographic parameters and inflammatory markers.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Oct 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa AbdelShafy mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695065
- Sponsor's protocol ID
- Echocardiogray in IBD
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Speckle Tracking Echocardiography in Early Assessment of Cardiac Function in Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT06695065
- Acronym / sponsor ID
- Echocardiogray in IBD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Value of speckle tracking echocardiography in early assessment of cardiac function in inflammatory bowel disease .
Detailed description
Ulcerative colitis (UC) is a common form of inflammatory bowel disease (IBD) that consists of chronic inflammatory disorders of the colon and the small intestine with unknown etiology. Chronic inflammation is the basis of complicated pathogenesis, and the course of the disease is often complicated by an immune response. Malnutrition, malabsorption and the involvement of organs other than those of the gastrointestinal tract are frequent consequences of the disease . Although extra-intestinal manifestations of IBD are common (ranging from 6% to 47%), cardiac involvement is rare.
Inflammatory bowel disease (IBD) is a known risk factor for cardiovascular disease (CVD). IBD patients have a two- to threefold increased risk of venous thromboembolism, particularly during acute flares when disrupted homeostasis of anti- and procoagulants leads to a hypofibrinolytic state. Cardiovascular manifestations in Crohn's disease (CD) and ulcerative colitis (UC) include conditions such as Takayasu's arteritis, pericarditis, and myocarditis. Chronic inflammation and altered lipid metabolism, along with long-term use of anti-inflammatory drugs (e.g., corticosteroids, TNF-α inhibitors), are thought to drive CV pathology in IBD. Additionally, chronic inflammation is linked to pathological collagen deposition in affected organs.
Although conventional echocardiography is a widely accessible and easy tool to detect cardiac abnormalities, novel echocardiographic techniques and indices offer easy, reproducible and quantitative information for evaluating left ventricle function and subclinical changes . Speckle tracking echocardiography (STE) is an advanced echocardiographic methodology for the quantification of myocardial function. STE has been successfully used to identify early subclinical cardiac involvement in a variety of asymptomatic populations with chronic diseases and unremarkable conventional echocardiography. Unlike earlier echocardiography techniques, two-dimensional speckle tracking echocardiography (2DSTE) is less angle-dependent. In addition, STE is not affected by the rotation of the heart and allows heart functions to be examined segment by segment from various echocardiographic views . Despite, studies have examined subclinical cardiac impairment in patients with IBD, to the best of our knowledge, none have explored the impact of ulcerative colitis activity on cardiac function through using STE.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group adult with ulcerative colitis | – | –50 Adult patients with ulcerative colitis |
| control group | – | –50 age and sex matched control group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- History: Demographic data; age, sex. History of the disease: onset, duration, medication. Family history of disease. History of comorbidities: hypertension, diabetes, ischemic heart diseases. Laboratory investigations: Fasting blood glucose, 2 hr postprandial and glycated haemoglobin A1c (HbA1c). Lipid profile: LDL, HDL, triglyceride, cholesterol. Inflammatory markers: CRP, ESR Complete blood picture Evaluation of Disease Severity Partial Mayo score consists three of the four components of the standard Mayo score, excluding endoscopic findings (stool frequency, rectal bleeding and physician's global assessment). Each component is assigned a score of 0-3, and total score ranges from 0 to 9 for each patient. -Echocardiographic Examination
Key inclusion criteria (3 listed)
- Age (18-60) yrs.
- Both sexes.
- Patients with IBD either in active form or in remission.
Key exclusion criteria (3 listed)
- Patients with ischemic heart disease. -Patients with other comorbidities affecting heart as uncontrolled hypertension or diabetes. -
- Pregnant females.
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subclincal cardiovascular events in IBD patients.
Time frame: through study completion, an average of 2 year
Assessment the predictive ability of Speckle TRACKING Echocardiograpy in development of subclinical cardiovascular events in IBD patients.
Relation between isease activity and cardiac function
Time frame: through study completion, an average of 2 year
Evaluation of the relationship between disease activity and cardiac function as measured by Speckle tracking Echocardiograpy.
1 secondary outcome
correlation of Speckle TRACKING Echocardiograpy findings with traditional echocardiographic parameters
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Echocardiography and Inflammatory Bowel Diseases, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Abdelshafy Mohamed (0109950131, Asma.shafy@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subclincal cardiovascular events in IBD patients. (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.